Deanxit and Rivotril in Tinnitus Patients

This study has been completed.
Information provided by:
University Hospital, Antwerp Identifier:
First received: January 30, 2009
Last updated: August 10, 2009
Last verified: August 2009
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Condition Intervention Phase
Drug: Deanxit
Drug: Lactose placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

Resource links provided by NLM:

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 3 weeks, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactose placebo
Drug: Lactose placebo
Lactose used as placebo
Experimental: Deanxit Drug: Deanxit
Deanxit 1x/day


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pure tone, narrow band noise or polyphonic tinnitus
  • unilateral or bilateral tinnitus
  • VAS ≥ 4

    • cochleair origin tinnitus
    • tinnitus present 3 months or more
    • age 18y or more
    • intake Rivotril 1mg/d
    • patient 'able to cooperate'
    • patient able to fill in TQ en VAS
    • No pontine angle pathology on MRI

Exclusion Criteria:

  • pulsatile tinnitus
  • pregnancy or breast feeding
  • contra-indications Deanxit
  • recovery myocard infarct
  • conduction disorder His
  • untreated glaucoma
  • MAO inhibitors: 15d stop
  • otosclerosis
  • middle ear pathologies
  • Ménière
  • somatic tinnitus
  Contacts and Locations
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Please refer to this study by its identifier: NCT00841230

Antwerp University Hospital
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Principal Investigator: Olivier Meeus, MD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Prof Dr P H Van de Heyning, Antwerp University Hospital Identifier: NCT00841230     History of Changes
Other Study ID Numbers: 8/46/260
Study First Received: January 30, 2009
Last Updated: August 10, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:

Additional relevant MeSH terms:
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms processed this record on November 27, 2015